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Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent

NCT ID: NCT01232023

Last Updated: 2010-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Indobufen healthy volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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100mg

Wild type UGT1A : 3 / Variant type UGT1A : 3

Group Type EXPERIMENTAL

Indobufen

Intervention Type DRUG

Single Oral Dose of

200mg

Wild type UGT1A : 3 / Variant type UGT1A : 3

Group Type EXPERIMENTAL

Indobufen

Intervention Type DRUG

Single Oral Dose of

400mg

Wild type UGT1A : 3 / Variant type UGT1A : 3

Group Type EXPERIMENTAL

Indobufen

Intervention Type DRUG

Single Oral Dose of

800mg

Wild type UGT1A : 3 / Variant type UGT1A : 3

Group Type EXPERIMENTAL

Indobufen

Intervention Type DRUG

Single Oral Dose of

Interventions

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Indobufen

Single Oral Dose of

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult males aged 19 to 50 years at screening.
* Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria

* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asan Medical Center

Principal Investigators

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Hyeong-Seok Lim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Pusan National University Yangsan Hospital

Pusan, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Sangmin Choe, M.D., Ph.D.

Role: primary

Hyeong-Seok Lim, M.D., Ph.D.

Role: primary

Related Links

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http://crc.amc.seoul.kr

Clinical Research Center, Asan Medical Center

Other Identifiers

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2009-0103

Identifier Type: -

Identifier Source: org_study_id